FDA.reportPublic FDA data

Thermacare Max Strength Lidocaine

Manufacturer
Clarion Brands LLC
Effective date
2025-12-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:22:11

Label at a glance#

ProductThermacare Max Strength Lidocaine
Active ingredientLIDOCAINE HCL, BENZYL ALCOHOL
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzyl alcohol 10%

Lidocaine HCl 4%

OTC - PURPOSE SECTION

Topical anesthetic

INDICATIONS & USAGE SECTION

Use

  • for the termporary relief of pain

WARNINGS SECTION

For external use only

Flammable

  • contents under pressure
  • keep away from fire, sparks, and heated surfaces
  • do not puncture or incinerate
  • exposure to temperatures above 130ºF may cause bursting

Do not use

  • in large quantities
  • on wounds, damaged, broken, or irritated skin
  • for more than one week without consulting a doctor

When using this product

  • use only as directed. Read and follow all directions and warnings on this label
  • avoid contact with the eyes and mucous membranes
  • do not bandage tightly or apply local heat such as a heating pad or a medicated patch
  • do not use with other topical analgesics

Stop use and ask a doctor if

  • rash or irritation develops
  • symptoms worsen or persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - WHEN USING SECTION

  • adults and children 2 years of age and older: apply to the affected area no more than 3 to 4 times daily
  • children under 2 years of age: consult a doctor before use

INACTIVE INGREDIENT SECTION

1,2 hexanediol

alcohol

aloe barbadensis leaf juice

aminomethyl propanol

bisabolol

caprylyl glycol

disodium EDTA

isopropyl alcohol

propylene glycol

vanillyl butyl ether

water

zingiber officinale (ginger) root extract

OTC - QUESTIONS SECTION

1-800-323-3383

DOSAGE & ADMINISTRATION SECTION

Benzyl alcohol 10%

Lidocaine HCl 4%

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

adults and children 2 years of age and older: apply to affected area no more than 3 to 4 times daily

children under 2 years of age: consult a doctor before use.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW! ThermaCare Heat Therapy

Soothing Heat 2x Dual Action Maximum Lidocaine

Heat + Max Strength Lidocaine Pain Relief

Fast Acting, Long Lasting

Penetrates to the Source

Number 1 Doctor Recommended

Spray NET WT 3oz (85g)

No Mess Application - 360 Degree Spray

Distributed by: Bridges Consumer Healthcare

811 Broad Street, Suite 600, Chattanooga, TN 37402

TC Heat Max Lido SprayTC Heat Max Lido Spray

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2369354benzyl alcohol 10 % / lidocaine HCl 4 % Topical SprayPSN1
2369354benzyl alcohol 0.1 ML/ML / lidocaine hydrochloride 40 MG/ML Topical SpraySCD1
2369354benzyl alcohol 10 % / lidocaine HCl 4 % Topical SpraySY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZYL ALCOHOL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69693-004-03Thermacare Max Strength Lidocaine1 mL in 1 CANISTERSPRAY11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69693-00469693-004-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
GINGERC5529G5JPQIACT
AMINOMETHYL PROPANOLLU49E6626QIACT
VANILLYL BUTYL ETHERS2ULN37C9RIACT
EDETATE DISODIUM7FLD91C86KIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
ALCOHOL3K9958V90MIACT
LIDOCAINE HCLV13007Z41AACTIR
ISOPROPYL ALCOHOLND2M416302IACT
BENZYL ALCOHOLLKG8494WBHACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
CAPRYLYL GLYCOL00YIU5438UIACT
WATER059QF0KO0RIACT
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
BISABOLOL24WE03BX2TIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Thermacare Max Strength LidocaineTHERMACARE MAX STRENGTH LIDOCAINEClarion Brands LLC44fed887-d1e0-d205-e063-6294a90ac4162025-12-02WarningsExact identifier
ndc (package): 69693-004-03
ndc (product): 69693-004
ndc11 (package): 69693000403
spl id: 44fed887-d1e1-d205-e063-6294a90ac416
spl set id: 44fed887-d1e0-d205-e063-6294a90ac416

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.